Pediculoses Clinical Trial
Official title:
Study of the Therapeutic Efficacy of the Combination Azithromycin + Ivermectin in the Treatment of Pediculosis in Senegal (IVERAZITH)
This is a prospective single-arm interventional study evaluating Therapeutic efficacy of a
combination of two pharmaceutical drugs, Azithromycin (AZIT) and Ivermectin (IVER)
administered orally in the treatment of head lice infestations. In case of persistence of
lice and / or nits on day 7, a second oral administration of combination Azithromycin +
Ivermectin will be considered.
The duration of the study period is 4 months, ie 1 month and ½ of inclusion and 2 months and
½ feedback. There will be a site initiation visit "site initiation visit" before inclusions
at D-7, two monitoring visits and a closing visit "close out visit" at the end of the
follow-up at 4 months.
The investigators will perform a clinical trial of efficacy, single-arm, until D28 from
volunteer subjects infested with head lice.
The two villages of the study (Dielmo and Ndiop) will be visited to explain the protocol and
obtain community permission to work on it. Schools will also be visited to inform teachers
and explain the protocol. The search for lice will be done by village women recruited for
this purpose. A systematic census by family will be performed. A clinical examination of the
hair will detect the persons infested with lice. On D-1, individual informed consent (an
assent for participants between the ages of 15 and 18) will be systematically obtained before
inclusion.
At D1, an interview and a complete clinical examination will be done on each subject
consenting. All volunteers meeting the inclusion criteria will be taken on a single arms. For
each voluntary participant selected fasting 1 hour before, the treatments will be
administered by the investigators of the study. After taking the AZIT + IVER dose, each
treated volunteer will be followed for 1 hour to observe the appearance of any side effects,
then a breakfast will be offered. Head lice and nits will be searched on D1, D7, D15 and D28
for each volunteer and the hair taken on D2, D5, D7, D15 and D28. Possibly, before each
treatment, Stool samples will be taken systematically on day 1 and after treatment on day 15
at any participant infested with head lice to identify intestinal parasites (load parasite in
helminthiasis) to evaluate also the efficacy of ivermectin on these parasites.
Sociodemographic, clinical, dose and type of material taken biological will be documented.
Data on co-infections (body lice, Sarcoptes scabeii) will also be collected and reported on
the study register. Each volunteer will have an identification number (ID). Only, the
principal investigator, the coordinator and the investigators can access sensitive
information if they exist. Data will be entered immediately by a data entry agent. The
investigators will sleep on the sites and will face possible cases of effects undesirable.
Regular visits will be scheduled on D2, D5, D7, D15 and D28. A clinical monitor will stay
with the team on the field of D2, D5, D7, D15 and D28. A Clinical Research Organisation (CRO)
will ensure the external monitoring of the study (1 site initiation visit, 2 monitoring
visits and 1 visit closing of the test). It will also be scheduled for a visit by Comité
National d'Ethique en Santé (CNERS) members on the field according to their schedule. All
willing participants and completing the eligibility criteria for entry into this study, will
be taken on a single treatment arm Azithromycin-Ivermectin in orodispersible tablets. The
evaluation of the answer therapy will be done on D7 and / or D15.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02974088 -
Neem Lotion With Combing for Lice
|
Phase 2 |